Promotion of Exercise Through Physical Therapy for Multiple Sclerosis: A Pilot Study

NCT06933160 | Recruiting DMC

• 2 other identifiers: HUM002663611R03HD111005-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity and exercise help manage symptoms like fatigue in people living with multiple sclerosis (MS). Despite research supporting physical activity participation, people with MS are often insufficiently active to reach health benefits. Promotional efforts that are sustainable within the United States healthcare system are needed. This project is a pilot randomized controlled trial examining the feasibility of a consultative physical therapy intervention for increasing physical activity engagement.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; physical activity; exercise; physical therapy

Outcome Measures

Primary Outcomes (1)

• Accelerometer-measured moderate-to-vigorous physical activity

  The duration (in minutes per day) of moderate-to-vigorous physical activity (MVPA) will be assessed using a waist-worn accelerometer (ActiGraph model GT3X+). Participants will wear the accelerometer attached to a belt around their waist during waking hours over a 7-day period. A greater duration of MVPA indicates a higher level of physical activity.

  From enrolment to end of treatment at 24 weeks

Secondary Outcomes (4)

• Total physical activity

  From enrolment to end of treatment at 24 weeks

• Fatigue

  From enrolment to end of treatment at 24 weeks

• Physical Function

  From enrolment to end of treatment at 24 weeks

• Exercise Self-efficacy

  From enrolment to end of treatment at 24 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

The experimental intervention is a 24-week progressive exercise intervention in which participants are supported through six physical therapy visits and are provided with educational material based on social cognitive theory. The individual sessions will provide tailored support for increasing physical activity behavior towards the recommended guidelines of 2-3 moderate aerobic activity sessions and two strength-training sessions per week. There are no drugs involved in the intervention.

Behavioral: PromPT-MS

Waitlist Control

NO INTERVENTION

24-week waitlist control condition

Interventions

PromPT-MS BEHAVIORAL

The experimental intervention is a 24-week progressive exercise intervention in which participants are supported through six physical therapy visits and are provided with educational material based on social cognitive theory. The individual sessions will provide tailored support for increasing physical activity behavior towards the recommended guidelines of 2-3 moderate aerobic activity sessions and two strength-training sessions per week. There are no drugs involved in the intervention.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of MS
• years and older
• Able to read and speak English sufficiently to allow for informed consent and active participation in the intervention sessions
• Relapse free for the past 30 days
• Willingness to attend all study visits and PT sessions for the duration of study
• Access to a smartphone
• Not sufficiently active as measured by the Godin Leisure Time Exercise Questionnaire score \<24
• Patient Determined Disease Steps score 0-3 or the ability to ambulate either independently or with the use of a cane (or similar device) for at least 75% of the time at baseline
• Less than 2 affirmative on the physical activity readiness questionnaire

You may not qualify if:

• Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
• Unable to attend study visits
• Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol.

Sponsors & Collaborators

• University of Michigan: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Dominique Kinnett-Hopkins, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Kinnett-Hopkins

CONTACT

734-647-5424; dlkh@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Kinesiology, School of Kinesiology

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: April 18, 2025
• Study Start: January 28, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)